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Renal and hepatic combined denervatIon in subjects with Uncontrolled Hypertension

Short Title: SPYRAL Gemini


Enrollment Status: Recruiting

NCT #: NCT06907147

Specialty Area: Cardiology

Condition Studied: Hypertension

Age Groups: Adult; Older Adult

Phase: Not Applicable


Study Information

Summary / Purpose

To evaluate the safety of multi-organ denervation with the Gemini System while providing evidence of blood pressure reduction in an uncontrolled hypertensive population.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18-80 years of age
  • Diagnosed with hypertension
  • Has a baseline office systolic blood pressure >150 mmHg and <180 mmHg and diastolic blood pressure >90 mmHg
  • No type 1 diabetes mellitus

What's Involved

Participation in the study will include:
  • A procedure called Multi-Organ Denervation (MDN) using an investigational product called the Gemini System
  • Medical imaging (angiogram, CT scan of the liver, and, for some participants, MRI of the liver)
  • Blood pressure monitoring (at visits and at home)
  • Glucose monitoring (for some participants)
  • Blood and urine samples
  • Antihypertensive medications being held (for some participants)

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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